Drug, Healthcare and Patient Safety最新文献

Hereditary amyloid transthyretin (ATTRv) amyloidosis is a devastating hereditary multisystemic disease affecting predominantly the peripheral and autonomic nervous systems and the heart. ATTRv is caused by mutations in the transthyretin (TTR) gene, leading to extracellular deposition of amyloid fibrils in multiple organs including the peripheral nervous system. If untreated, it is associated with a fatal outcome 10-12 years after disease onset. Different treatments are available for patients with ATTRv polyneuropathy. Tafamidis 20 mg is approved in Europe since 2011 for early stages of ATTRv polyneuropathy (stage I - able to walk without support) and it is recommended as first-line therapy in these patients. Tafamidis is a TTR stabilizer that selectively binds to TTR and kinetically stabilizes both wild-type native TTR and mutant TTR. Consequently, it has the potential to prevent the amyloidogenic cascade initiated by TTR tetramer dissociation into its monomers and subsequent misfolding and aggregation. Tafamidis is an oral drug, taken once per day, with proved efficacy, safety and tolerability in ATTRv-PN patients as demonstrated in different clinical trials and open-label extension studies as well in clinical practice setting with around 10 years of experience. Tafamidis treatment started in the earliest stages of the disease is associated with better neurological outcomes. A multidisciplinary approach in referral centres is also fundamental for monitoring patients to assess individual response to treatment.

Testosterone deficiency is diagnosed by a serum total testosterone level below 300 ng/dL in combination with symptoms such as decreased energy and libido. These symptoms can be ameliorated by restoring serum testosterone to the physiologic range with testosterone therapy (TT). There are numerous forms of testosterone therapy, such as injectable, transdermal, nasal, and subcutaneous applications. There are also multiple formulations of injection, such as testosterone cypionate, testosterone enanthate, and testosterone undecanoate. Testosterone undecanoate (TU) is a long-acting ester formulation of testosterone that can be provided in an injectable or oral form. Oral testosterone undecanoate is marketed as Andriol, Jatenzo, Tlando, and Kyzatrex. Oral TU provides a convenient option for many patients, which may increase compliance with TT. Injectable testosterone undecanoate is marketed as Aveed and Nebido. Injectable TT remains the most cost-effective therapeutic option and is appropriate for most patients as an initial therapy. This review describes the pharmacokinetics of these testosterone undecanoate products and provides a guide for prescribers using these medications. While many forms of testosterone are appropriate for TT, a patient-centered discussion focused on goals of care should best guide physician prescription of these medications.

Background: The higher demand for surgical services during the advancement of the COVID-19 pandemic has resulted from the need for a pre-admission negative result, the need for extra resources, and a shortage of skilled expertise. This quality improvement project aimed to reduce the in-hospital preoperative waiting time of elective cases to less than 24 hours.

Methods: The study was conducted in a tertiary care center. Following the collection of baseline data, we formed a multidisciplinary team to analyze the root causes and intervention ideas of delay using fishbone and driver diagrams, respectively. We prioritize key drivers and implemented several low-cost interventions using Plan-Do-Study-Act (PDSA) model. We monitored the average in-hospital preoperative waiting time of patients.

Results: Overall, in-hospital preoperative waiting time for elective cases has been reduced from a baseline of 4.89 days to 1.32 days on average by the end of 10 months of initiating the project. Similarly, monthly elective case cancellation rate due to COVID-19-related reason has been reduced from baseline 62.5% of the total cancellation to 0%. Due to this, the average monthly inpatient bed utilization has increased from 2.21 patients per month during pre-COVID-19 period to 5.9 patients per month in each bed of the surgical ward by the end of the project.

Conclusion: The implementation of a quality improvement project can optimize operation theatre efficiency, inpatient bed utilization, and reduce the surgical backlog. Meticulous and rigorous effort has to be laid down to do root cause analysis, generate feasible change ideas, and continuous follow-up, and testing of multiple PDSA cycles is required to impact an improvement and sustain it in the long run. The emergence of COVID-19 pandemic could be used as an opportunity to reduce the length of stay in the hospital.

Background: Opioid utilization and management in an inpatient rehabilitation setting have not been widely described, despite the unique opportunities that exist in this setting to support opioid stewardship across transitions in care. We aimed to characterize opioid utilization and management by interprofessional teams across a large, inpatient rehabilitation setting after incorporation of opioid stewardship principles by pharmacists as part of their daily practice.

Patients and methods: This was a retrospective chart review at Toronto Rehab, University Health Network, Toronto, Canada. Patients with admission orders for any opioid from November 2017 to February 2018 were included. Complex continuing care and palliative care patients were excluded. Descriptive statistics were primarily used to describe the data as well as univariate linear regression to compare associations with milligram morphine equivalent (MME) reduction.

Results: A total of 448 patients were included. A reduction in total daily MME was seen in 49% (n=219) of the patients during their inpatient stay, with 73% (n=159) of these patients having a reduction of ≥50%. Sixty-nine percent (n=311) of the patients received an opioid prescription at discharge, with most scheduled (90%, n=98) with a supply of less than 30 days. Rehabilitation length of stay was correlated with a MME decrease during rehab (p<0.01), suggesting that longer lengths of stay contributed to a greater reduction in MME. Patients with chronic opioid use prior to acute care admission (p=0.01), and those who started extended-release opioids during acute care (p=0.02) were significantly less likely to discontinue opioids during rehab stay.

Conclusion: Opioid utilization and management in the setting of opioid stewardship across inpatient rehab and transitions of care were characterized. Opportunities exist for further quality improvement initiatives within inpatient rehabilitation and acute care settings to identify and support patients with complex pain management needs.

Autosomal dominant polycystic kidney disease, also known as ADPKD, is the most common hereditary kidney disease, affecting different age groups. ADPKD can eventually lead to end-stage renal disease. The etiology of ADPKD is genetic, resulting in the formation of cysts containing fluids on the kidneys. Patients with ADPKD present a range of symptoms following a decline in kidney function. Pain, stones, proteinuria and osteoporosis are few of the many symptoms, resulting from decreased kidney function. Tolvaptan, a selective V2 receptor antagonist, is the etiological treatment used for ADPKD. In this paper, we conducted a systematic review of the literature between 2011 and 2021 to gather data regarding the tolerability and efficacy of tolvaptan use in ADPKD. A total of 22 trials were reviewed. Tolvaptan efficacy in the trials was measured using changes in eGFR or changes in total kidney volume. Results showed that tolvaptan use in ADPKD was associated with a slower decline in kidney function and a decrease in total kidney volume. Side effects of this drug include polyuria, nocturia and polydipsia along with hepatotoxicity. The two biggest trials, TEMPO and REPRISE, change in eGFR from pre-treatment baseline to post-treatment was 1.3 mL/min/1.73 for REPRISE and 1 mL/min/1.73 for TEMPO 3:4. A mean decrease of 49% in total kidney volume from baseline to post-treatment was found in the TEMPO 3:4 study.

Purpose: Our aim was to inform a new definition of wrong-patient errors, obtained through an analysis of incident reports related to medication errors.

Methods: We investigated wrong-patient medication errors in incident reports voluntarily reported by medical staff using a web-based incident reporting system from 2015 to 2016 at a university hospital in Japan. Incident report content was separately evaluated by four evaluators using investigational methods for clinical incidents from the Clinical Risk Unit and the Association of Litigation and Risk Management. They investigated whether it was the patient or drug that was incorrectly chosen during wrong-patient errors in drug administration in incident reports and assessed contributory factors which affected the error occurrence. The evaluators integrated the results and interpreted them together.

Results: Out of a total 4337 IRs, only 30 cases (2%) contained wrong-patient errors in medication administration. The cases where the intended drugs were administered to incorrect patients occurred less frequently than cases where the wrong drugs were administered to the intended patients through the investigation of wrong targets. After a discussion, the evaluators concluded that the patient - drug/CPOE screen mismatch, caused by choosing the wrong patient, drug, or CPOE screen (mix-ups), occurred in the wrong-patient medication errors. These errors were caused by three conditions: (1) where two patients/drugs were listed next to one another, (2) where two patients' last names/drugs' names were the same, and (3) where the patient/drug/CPOE screen in front of the staff involved was believed to be the correct one. Additionally, these errors also involved insufficient confirmation, which led to failure to detect and correct the mismatch occurrences.

Conclusion: Based on our study, we propose a new definition of wrong-patient medication errors: they consisted of choosing a wrong target and insufficient confirmation. We will investigate other types of wrong-patient errors to apply this definition.

Background: Though vaccines are generally considered extremely safe and effective, they have been associated with some serious adverse events following immunization (AEFIs). AEFIs might be related to either the vaccine, immunization error, anxiety related to immunization, and/or coincidental events. If they are not reported and investigated in timely fashion, they can create rumors and confidence gaps. In the last few years, reporting AEFIs in the Central Region of Eritrea, compared to other regions, has been found to be very low, with the root cause for this variation unknown, making intervention strategies challenging. This study was conducted to assess nurse practitioners' knowledge and perceptions on AEFI surveillance and barriers to reporting in the region.

Methods: An analytical cross-sectional study was conducted among all nurse practitioners who were directly or indirectly involved in immunization services working in all health facilities of the region. Data were collected between October 2019 and February 2020 using an interview-based questionnaire. Percentages and medians (IQR) were used as descriptive statistics, and Mann-Whitney and Kruskal-Wallis tests were used as inferential tools.

Results: A total of 130 respondents with a median age of 40 (IQR 23) years were included in the study. The overall median (IQR) knowledge score of the respondents on AEFI surveillance was 87.50 (19) out of 100. Furthermore, median (IQR) comprehensive perception score was 70 (20) out of 100 (range 40-95). Shortage of motivation and not knowing how to report were identified as the main barriers to reporting AEFIs.

Conclusion: Knowledge and perceptions of nurse practitioners in the Central Region on AEFI surveillance were generally encouraging. They should however need to be further trained on the basics of AEFI surveillance to bridge the identified barriers to reporting.

Drug hypersensitivity is an inflammatory or immune reaction induced by drugs. It can be fatal if not appropriately treated and cause the risk of long-term complications. Sulfonamides are classified as antimicrobial drugs with a broad spectrum effective for gram-positive and gram-negative bacteria. This antibacterial agent works by competitively inhibiting folic acid synthesis, which prevents the growth and proliferation of microorganisms. In its use as antibiotics, sulfonamides can also cause adverse reactions in specific individuals. It has been widely reported that sulfonamide antimicrobials cause hypersensitivity reactions mediated by IgE or T cells. This review identifies symptoms or signs that can appear, as well as genes associated with sulfonamide hypersensitivity reactions, as sulfonamide may cause hypersensitivity in the form of uveitis, skin rash, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), parotitis, angioedema, drug reaction with eosinophilia and systemic symptoms (DRESS), and pruritus. In addition, several genes were found to be associated with sulfonamide hypersensitivity, including HLA-A29, HLA-B12, HLA-DR7, HLA-B44, and HLA A*11:01.

Hyperkalemia remains one of the most difficult consequences of disease state and treatment for patients with chronic kidney disease, heart failure, and diabetes. Controlling hyperkalemia can be difficult, but has become easier with the introduction of novel oral potassium binders. Patiromer was approved in 2015 for the treatment of hyperkalemia by the FDA in the United States. Several pivotal trials proved its efficacy, safety, and improved tolerability compared with previous hyperkalemia treatments. Additionally, many real-world publications and trials have given deeper insights into the capabilities of patiromer. We discuss improved disease state outcomes with combining patiromer with RAASi. This paper will also highlight new trials forthcoming that are highly anticipated to expand the possibilities in using patiromer to improve outcomes and populations.